Back to resultsNoninvasive Positive Pressure Ventilation in Overlap Syndrome
Primary Purpose
COPD, Sleep Apnea Syndromes, Non-invasive Positive Pressure Ventilation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NIPPV
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
Inclusion Criteria:
- patients with COPD and sleep apnea dyspnea syndrome
Exclusion Criteria:
- patients with non-stable hemodynamics;
- patients with limited life expectancy;
- patients with other severe respiratory diseases;
- patients with motor neuron diseases;
- patients with contraindications for NIPPV
Sites / Locations
- Renmin Hospital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Interventional group
Arm Description
NIPPV as treatment of OS
Outcomes
Primary Outcome Measures
COPD acute exacerbations
total times of COPD acute exacerbations
Secondary Outcome Measures
COPD assessment test (CAT) score
symptom score of COPD
modified British medical research council (mMRC) score
dyspnea score
all-cause mortality
survival rate in %
Full Information
NCT ID
NCT03184714
First Posted
June 8, 2017
Last Updated
June 10, 2017
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03184714
Brief Title
Noninvasive Positive Pressure Ventilation in Overlap Syndrome
Official Title
The Effectiveness of Noninvasive Positive Pressure Ventilation Treatment in Overlap Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2017 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic obstructive pulmonary diseases (COPD) coexisting with obstructive sleep apnea is called overlap syndrome (OS). Patients with OS seem to have worse prognosis than patients with only one disorder. Noninvasive positive pressure ventilation is an efficient treatment in obstructive sleep apnea, but the effectiveness in improving outcomes of OS patients is still not fully investigated. The aim of this non-randomized concurrent control trial is to evaluate noninvasive positive pressure ventilation's effectiveness in OS patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Sleep Apnea Syndromes, Non-invasive Positive Pressure Ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
non-invasive positive pressure ventilation
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
292 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
NIPPV as treatment of OS
Intervention Type
Device
Intervention Name(s)
NIPPV
Intervention Description
BiPAP treatment for 3 years
Primary Outcome Measure Information:
Title
COPD acute exacerbations
Description
total times of COPD acute exacerbations
Time Frame
3 years
Secondary Outcome Measure Information:
Title
COPD assessment test (CAT) score
Description
symptom score of COPD
Time Frame
3 years
Title
modified British medical research council (mMRC) score
Description
dyspnea score
Time Frame
3 years
Title
all-cause mortality
Description
survival rate in %
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with COPD and sleep apnea dyspnea syndrome
Exclusion Criteria:
patients with non-stable hemodynamics;
patients with limited life expectancy;
patients with other severe respiratory diseases;
patients with motor neuron diseases;
patients with contraindications for NIPPV
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ke Hu, MD
Phone
18971035988
Email
hukejx@163.com
Facility Information:
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke Hu, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Noninvasive Positive Pressure Ventilation in Overlap Syndrome
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